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Ge Hualun Medical Systems Co. , Ltd.

12 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
OEC One CFD (K253269)Ge Hualun Medical Systems Co. , Ltd.2025-11-26
Definium Tempo Select (K250788)Ge Hualun Medical Systems Co. , Ltd.2025-08-28
OEC One ASD (K240828)Ge Hualun Medical Systems Co. , Ltd.2024-12-27
Definium Pace Select ET (K242678)Ge Hualun Medical Systems Co. , Ltd.2024-10-01
Definium Pace Select (K231892)Ge Hualun Medical Systems Co. , Ltd.2023-09-12
Discovery XR656 HD with VolumeRad (K191699)Ge Hualun Medical Systems Co. , Ltd.2019-07-24
OEC One (K182626)Ge Hualun Medical Systems Co. , Ltd.2018-11-16
Optima XR646 HD (K173612)Ge Hualun Medical Systems Co. , Ltd.2017-12-11
OEC One (K172700)Ge Hualun Medical Systems Co. , Ltd.2017-11-09
Discovery XR656 HD (K172869)Ge Hualun Medical Systems Co. , Ltd.2017-10-20
OEC Elite MiniView (K171800)Ge Hualun Medical Systems Co. , Ltd.2017-07-12
Optima XR646 (K143270)Ge Hualun Medical Systems Co. , Ltd.2015-02-18

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Every clearance here is in the API, with alerts when new ones post.